UK | New Patient Information Quality Standards, Design and Review Principles
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ITALY | Delay in Establishing Territorial Ethics Committees (CETs) in the Provinces of Trento and Bolzano
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ITALY | Mandatory Substantial Amendment to Notify Transition to New Territorial Ethics Committees (CET)
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USA – FDA Proposes New Medication Guide for Patients
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GLOBAL| CIOMS Publishes Draft Report on Real-World Data and Real-World Evidence in Regulatory Decision Making GalleryGLOBAL| CIOMS Publishes Draft Report on Real-World Data and Real-World Evidence in Regulatory Decision Making
2023, Data Privacy and Data Protection, Global, June 2023, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
GLOBAL| CIOMS Publishes Draft Report on Real-World Data and Real-World Evidence in Regulatory Decision Making
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EU | New Commission Implementing Regulation (EU) 2023/1194 on Transitional Provisions for Products without an Intended Medical Purpose
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CANADA | Revised Letter of Initial Contact Template
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EU | Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report
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CHINA | New Measures for Ethical Review of Life Sciences and Medical Research Involving Humans
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